Osteoarthritis Topical Treatment
ANTIPAIN
A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee
1 other identifier
interventional
75
1 country
5
Brief Summary
This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment. A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2011
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedDecember 21, 2011
December 1, 2011
6 months
December 15, 2011
December 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale (VAS) Pain scale
14 days
Study Arms (2)
Ibuprofen
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female patients aged at least 40 years.
- Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system.
- Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening.
- pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated.
You may not qualify if:
- Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain
- Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned.
- Female patients who are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioChemics, Inc.lead
Study Sites (5)
Unknown Facility
Sankt Gallen, 9000, Switzerland
Unknown Facility
Schaffhausen, 8200, Switzerland
Unknown Facility
Zurich, 8001, Switzerland
Unknown Facility
Zurich, 8050, Switzerland
Rheumaklinik und Institut für Physikalische Medizin Universitätsspital
Zurich, 8091, Switzerland
Related Publications (1)
Varadi G, Zhu Z, Blattler T, Hosle M, Loher A, Pokorny R, Frey D, Carter SG. Randomized clinical trial evaluating transdermal Ibuprofen for moderate to severe knee osteoarthritis. Pain Physician. 2013 Nov-Dec;16(6):E749-62.
PMID: 24284856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen Carter, Ph.D.
BioChemics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 21, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 21, 2011
Record last verified: 2011-12